Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves
Resource Optimization & Innovation LLC is recalling 90 sterile Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile field breach) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 90 sterile Regard custom procedure trays (Item Number: 800623002, NU0787B). The recall is limited to units with the expiration date 2018-07-30 and code 037598B. These trays were distributed in the United States to locations in California and Texas, including Neuro-Medical Center Santa Rosa.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for medical procedures. The agency has classified this as a Class II recall.
Healthcare facilities and consumers who possess these specific trays should stop using them immediately. The manufacturer is responsible for the recall and should be contacted for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 90
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 037598B Exp Date: 2018-07-30
Distribution
Part of a larger recall action
This product is one of 135 recalled by Resource Optimization & Innovation Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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